Overview

Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010 in Patients With EGFR T790M Positive NSCLC

Status:
Active, not recruiting

Trial end date:
2023-03-01

Target enrollment:

Participant gender:

Summary

AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010 in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Hangzhou ACEA Pharmaceutical Research Co.,Ltd.

Collaborators:

Acea Bio (Hangzhou) Co., Ltd.
Guangdong General Hospital
Guangdong Provincial People's Hospital

Treatments:

Abivertinib